Clinical Research Regulatory Manager

TL;DR

As a Clinical Research Regulatory Manager, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Dotting all your i's and crossing all your t's is a top priority for you. You are a superstar at Word, Excel and organization of electronic documents and files. When faced with a challenge, you grab your resources, open your manuals, and search until the answer can be found! You are versed in FDA guidelines and ICH GCP and are always striving to align with best practices. You’re up to date with the latest and greatest regulations in the industry and you ensure updates to processes are implemented company-wide. You don’t shy away from defending our SOPs to make certain we are adhering to them 100% of the time. Problem solving and implementing processes that work are your jam! You have a minimum of 1 year clinical research experience. Bachelor's degree required.

What you will own & improve

• Manage Regulatory Compliance Company-wide: Accomplishes regulatory affairs department objectives by selecting, orienting, training, coaching, and disciplining employees. Hires, trains, communicates job expectations and conducts performance evaluations. Oversee staff who support all regulatory tasks and perform quality checks. 
• Regulatory Department Task Management: Manages Trial Master File maintenance, IRB reporting, submissions, approval processing, and more. Rolls out protocol and informed consent amendment approvals. Oversee staff who support with these tasks. 
• Credentialing: Maintain CVs for all physicians, staff, and study staff members; update appropriately. Track GCP training expirations and issue reminders for completion; file certificates. Maintain current medical malpractice, general liability, and workers compensation documentation for all physicians. 
• Calibration & Certifications: Track and manage equipment calibration across all sites including monthly and annual calibration. Schedule and orchestrate annual recalibrations; file certificates. Obtain and maintain laboratory certifications (e.g. CLIA) for each site, track certifications, and apply for renewals.   
• Study Start-Up: Acting project manager, taking the study through the start up process to ensure prompt timelines are met. Prompt and accurate execution of initial regulatory packets. Collects training documentation and ensures completion of the delegation of authority log prior to initiation of protocol activities. Ensures the study hits the ground running when green light is received.
• Internal Monitoring & Mock Audits: Conduct thorough quality assurance checks of source and regulatory and provide staff retraining as applicable. Oversee staff who perform these duties. Conduct mock inspections of trials across all sites including those out of state, document findings, conduct reviews with staff, and support in the implementation of CAPA with on-site staff.
• Audit Management: Serve as the point person for Sponsor Audits. Manage pre-audit activities to ensure proper quality assurance of regulatory and source, facilitate pre-audit meetings with staff and doctors, and manage day-of audit activities. Compose audit finding responses, implement corrective action, and conduct retraining based on the audit report. 
• SOP Creation & Maintenance: Review SOPs on a regular basis to ensure adherence and update as necessary. Perform SOP review and retraining with staff. Monitor for gaps and create new SOPs where applicable. 

• Protocol Deviation Review & Approval: Track, edit, and approve protocol deviation reporting. Observe trends and retrain staff as necessary. Report eligible deviations based on IRB guidelines.

• Sponsor/CRO Monitor Relations: Maintain and develop business relationships with Sponsor/CRO staff. Participate in study acquisition activities including completion of CDAs and Feasibility Questionnaires. Schedule and carry out pre-study visits.
• Study Meetings: You manage all of them with the support of site staff and the regulatory department (PSV, SIV, IMV, COV). Attend Investigators’ Meetings to represent DocTrials and form business relationships with key players.
• Monitor Management: Manage monitor site visits and delegate site staff responsible for facilitating the visit when necessary. Facilitate meetings between Sponsor/CRO representatives and PIs. Track receipt of monitor follow-up letters, execute to do lists, resolve items/queries, and provide follow-up responses to outstanding items. 
• Study Close-Out:  Manage the QA and archiving process and organization 

What you already know and do

• You are a CTMS super user completing tasks within Clinical Trial Management Software (CTMS), eSource, eDocs, and more. You can create and update source as required by protocol amendments, clarification letters, etc.  
• Process important study information through the project management platform, Basecamp. Relay information, study bulletins, newsletters, and memos to the team.
• Advanced regulatory and quality assurance skills like how to properly add staff to studies, execute initial regulatory packets in a timely manner, prompt IRB correspondence/submissions, and how to prepare for and carry out successful monitoring visits. 
• Moderate knowledge of ICH-GCP and FDA guidelines. 
• How to organize and maintain order at the site - manage study supplies, inventory, and ordering.
• How to stay personally organized and manage a large variety of tasks and timelines.
• Possess strong written, verbal and interpersonal skills.

What you will learn

• How to grow a Regulatory and Quality Assurance department packed with internal monitoring processes, inspection team, and regulatory compliance committee.
• How to cultivate a positive working relationship with all of our customers (Sponsor/CRO & Physician Specialists). Further business development by participating in study acquisition activities, identifying study leads, and following up until selection.

About the Team

This role reports to our Director of Clinical Research.

Local travel is required.

Benefits at DocTrials

Competitive salary

Health insurance

Dental & vision

Paid time off

Bonus structure

Cell phone stipend

Mileage reimbursement

Retirement plan

Flexible schedule

Company adventures

Values at DocTrials

Align Your Daily Priorities

Roll Out the Red Carpet

Be obsessed about learning

Show Up Ready

What Can We Do?

Don’t Panic

Don’t Work in a Bubble

Recognize the Gray

Have a positive purpose

About Us

DocTrials' culture is guided by our values and behavior. Our success depends on how much we care for each other, our customers, and our community.

DocTrials is an alliance of physician sites specializing in the conduct of clinical studies within their private practices. Sites in the alliance work under DocTrials' core standard operating procedures and quality control measures that provide a methodology ensuring the highest quality control and best practice utilization across sites. This provides assurance and confidence to sponsors that they will achieve quality data in the most efficient and timely manner. DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease.